Validation Engineer

Amgen Inc. (IR); Hyderabad; On-site; INR 1,800,000 - 2,400,000; Full time

Job summary

Amgen Inc. in Hyderabad, India, is seeking a Validation Engineer to ensure compliance across Process Development and Manufacturing. The role supports the Benchtop product team with computer validation across the Operations footprint.

The candidate will develop validation documentation, test protocols, and IQ/OQ scripts, working with clients to align with GxP requirements and regulatory expectations. Strong knowledge of GAMP and 21 CFR Part 11 is essential.

Qualifications

• 3–5 years in pharmaceutical CS validation and GAMP alignment.
• Experience with FDA/EMEA CFR 21 Parts 11 compliance.
• Ability to understand business processes and validate systems.
• Expertise with ALM testing and Veeva suite usage.
• Familiarity with MS Office (Excel, PowerPoint, Visio, Project) and related tools.

Responsibilities

• Advising clients on how to meet compliance requirements using a risk-based approach.
• Develop validation documentation and SOPs for various GxP applications.
• Develop test protocols that thoroughly test business requirements.
• Provide test execution oversight and assist with deviation recommendations; develop validation plans to ensure systems meet GxP requirements.
• Collaborate with clients to develop URS, FRS, and/or DS as required; develop IQ/OQ scripts.
• Develop IQ/OQ scripts as required.

Skills

GxP compliance

Computer Systems Validation

GAMP 5

FDA CFR Part 11

IQ/OQ/PQ scripting

Veeva suite

ALM testing

Regulatory liaison

Education

Master’s degree in a relevant field

Bachelor’s degree in a related field

Tools

ALM software

Veeva (CDocs, QMS, RIM, DocuSign)

Smartsheets

Salesforce

Tableau

Job description

Career Category Information Systems Job Description Join Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Validation Engineer

You will play a pivotal role in ensuring compliance across the Process Development and Manufacturing. The Validation Engineer will assist the Benchtop product team with all aspects of the computer validation process across the Operations footprint.

Roles & Responsibilities

• Advising clients on how to meet compliance requirements using a risk-based approach.
• Develop validation documentation and standard operating procedures for various GxP applications.
• Develop test protocols that thoroughly test business requirements.
• Provide test execution oversight and assist with deviation recommendations as required, work with clients to develop validation plans to ensure that, at the end of the project, the system meets GxP requirements.
• Work with client business functions and subject matter experts to develop User Requirements Specification, Functional Requirements Specification, and/or Design Specifications as required Development of test / validation scripts based on software design and configurations.
• Develop IQ/OQ scripts as required.

Basic Qualifications

Master’s degree with 8 - 12 years of experience in validation/regulatory or related field OR Bachelor’s degree with 10 - 14 years of experience in validation/regulatory or related field OR Functional Skills:

Must-Have Skills

• Demonstrated experience with minimum of 3 to 5 years in pharmaceutical industry, focusing on Computer Systems Validations / GAMP Experience with regulatory agencies – FDA, EMEA, CFDA, and other regulatory agencies Thorough understanding of the principles of GAMP, SDLC methodologies and testing best practice.
• Ability to understand existing and new business processes and requirements to ensure proper implementation and validation of systems.
• Expertise with ALM testing and ALM software Expertise in use – Veeva (all modules – CDocs, QMS, RIM, DocuSign, etc) Fluent knowledge of rules and regulations: GAMP 5, 21 CFR Part 11 Compliance and CFR Part 210, 211 Compliance.

Preferred Skills

• Ability to work independently, excellent problem solving and professional written communications skills.
• Fluent in Microsoft Office suite Including (Excel, Power Point, Visio, Project), Experience with Smartsheets, Salesforce, Tableau a plus FDA Audit experience a plus & working with regulatory agencies Experience with instrument qualifications (IQ/OQ), validation plans, regulated workflows.

Soft Skills

• Excellent leadership and team management skills.
• Strong transformation and change management experience.
• Ability to work effectively with global, virtual teams.
• Excellent analytical and troubleshooting skills.
• Ability to manage multiple priorities successfully.
• Strong presentation and public speaking skills.
• Strong verbal and written communication skills.High degree of initiative and self-motivation.

What you can expect of us

From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.

Equal Opportunity

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

About Amgen

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. For more information, visit www.amgen.com and follow us on www.twitter.com/amgen